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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinalysis controls (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJW
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
QUANTIMETRIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRECK
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Loose or Intermittent Connection 1
Migration 1
Loss of or Failure to Bond 1
Total Device Problems 3

Recalls
Manufacturer Recall Class Date Posted
1 Lin-Zhi International Inc II Mar-12-2014
2 Quantimetrix Corporation III Jun-20-2018

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